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Analyse-it Method Validation Edition
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What Analyse-it Method Validation Edition is
Analyse-it Method Validation Edition is Windows desktop software that runs inside Microsoft Excel for method-validation statistics. It works with data already stored in Excel workbooks (.xlsx) and provides configurable statistical tests, regression models and plots. Its analyses cover method comparison, precision, linearity, detection limits, diagnostic accuracy and reference intervals, with coverage associated with CLSI EP05-A3, EP06-Ed2, EP09-A3, EP10-A3-AMD, EP12-A2, EP14-A3, EP15-A3, EP17-A2, EP21-A, EP24-A2 and EP28-A3c. Method-comparison tools include Passing-Bablok, Deming and Weighted Deming regression, Bland-Altman limits of agreement, bias tests and commutability analysis. Precision features include nested variance components, precision profiles, and checks against manufacturer claims. Diagnostic tools provide ROC curves, AUC comparisons, sensitivity, specificity, likelihood ratios and decision thresholds. Reference-interval functions support estimation, partitioning, outlier screening, transformations, and transfer or verification. A 15-day trial includes all features but watermarks analyses and blocks copying results.
Who it suits
It suits IVD manufacturers, clinical laboratories and researchers working on method verification or submissions. Users need Windows and desktop Microsoft Excel; macOS and Excel Online are unsupported.
What it does well
- Covers multiple CLSI-associated analyses
- Runs as an Excel COM add-in
- Includes method-comparison regression tools
- Provides precision and trueness checks
- Offers a 15-day full-feature trial
What to know first
- No free plan
- Windows and desktop Excel required
- Trial results are watermarked
- Trial blocks copying results
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| Method Validation Edition — annual license | Annual subscription · Method validation and statistical analysis in Excel | $475 a year |
| Method Validation Edition — perpetual license | Perpetual licence · Perpetual license | $1,155 a month |
| Method Validation Edition | From US$ 475 a year · Per-user or floating licence · Annual or perpetual licence options · Price varies by users and licence choices | $475 a year |
As analyse-it.com lists them, read 23 Sept 2026. The maker's own page has the final word.
Verdict
This edition brings broad method-validation statistics into existing Excel workbooks. Its configurable analyses suit laboratory and IVD work, but the Windows-and-Excel requirement and paid licensing narrow the fit.
Facts from Analyse-it Method Validation Edition's own pages
- CLSI coverage
- The edition covers analyses associated with CLSI EP05-A3, EP06-Ed2, EP09-A3, EP10-A3-AMD, EP12-A2, EP14-A3, EP15-A3, EP17-A2, EP21-A, EP24-A2 and EP28-A3c. · analyse-it.com, 11 Oct 2026
- Data import formats
- Microsoft Excel workbooks (.xlsx); runs on data in the existing workbook · analyse-it.com, 23 Sept 2026
- Deployment
- desktop · analyse-it.com, 23 Sept 2026
- Diagnostic accuracy
- Diagnostic features include ROC curves, AUC comparisons, sensitivity, specificity, likelihood ratios and decision thresholds. · analyse-it.com, 11 Oct 2026
- Excel integration
- Analyse-it runs as a COM add-in inside the desktop version of Microsoft Excel for Windows and is incompatible with Excel Online. · analyse-it.com, 11 Oct 2026
- Free plan
- No · analyse-it.com, 23 Sept 2026
- Intended users
- The product is described for IVD manufacturers, clinical laboratories and researchers, including work supporting 510(k) submissions and laboratory method verification. · analyse-it.com, 11 Oct 2026
- Method comparison
- Method comparison tools include Passing-Bablok, Deming and Weighted Deming regression, Bland-Altman limits of agreement, bias tests and commutability analysis. · analyse-it.com, 11 Oct 2026
- Not a guided protocol wizard
- The analyses are configurable statistical methods rather than scripted protocol wizards or fixed workflows. · analyse-it.com, 11 Oct 2026
- Precision and measurement system analysis
- Precision features include nested variance component designs, precision profiles and verification of precision and trueness against manufacturer claims. · analyse-it.com, 11 Oct 2026
- Purpose
- Method Validation Edition provides statistics and plots for method comparison, precision, linearity, detection limits and reference intervals. · analyse-it.com, 11 Oct 2026
- Quality and validation
- The company says its numerical accuracy is validated against NIST Standard Reference Datasets and describes unit, integration and system testing and code reviews. · analyse-it.com, 11 Oct 2026
- Reference intervals
- Reference interval tools cover estimation, partitioning, outlier screening, transformations, and transfer or verification against a new procedure or population. · analyse-it.com, 11 Oct 2026
- Regression models
- Yes · analyse-it.com, 23 Sept 2026
- Regulated use
- The company says its development and validation process covers GAMP 5, FDA CSA and 21 CFR Part 11. · analyse-it.com, 11 Oct 2026
- Statistical tests
- Yes · analyse-it.com, 23 Sept 2026
- Support
- The company offers direct email support and says its help team typically replies within a few hours. · analyse-it.com, 11 Oct 2026
- Supported environment
- The download page lists Excel 365 or Excel 2016 onwards and Windows 10 or 11, or Windows Server 2016 onwards; macOS is unsupported. · analyse-it.com, 11 Oct 2026
- Trial
- The free 15-day trial includes every feature from every edition and requires no payment information; trial analyses have a watermark and results cannot be copied out of the workbook. · analyse-it.com, 11 Oct 2026
Where Analyse-it Method Validation Edition stands on Freedom251
- Statistical Analysis Software#91 of 107